Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

First administration of a single and increasing doses of BDT272 to assess its safety and pharmacokinetic in healthy volunteers

This is a very early study, often called a Phase 1 trial, where scientists are testing a new medicine named BDT272 for the first time in people. They are looking for healthy adult volunteers to take part. The main goals are to find out if the medicine is safe when given in different amounts and to understand how the body processes it. This information is crucial for developing new treatments for moderate to severe pain. By joining this study, you would help doctors learn important details about BDT272, which could potentially benefit many people suffering from pain in the future. It's an essential first step in bringing new medicines to those who need them.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Biodol Therapeutics

Enrolment target

Start

08 Nov 2024

Moderate to severe pain

What is this study about?

This research is about a new medicine called BDT272. It's designed to help people who have moderate to severe pain. Scientists need to test new medicines very carefully to make sure they are safe and work properly before they can be used widely.

This particular study is a very early stage of testing, sometimes called a 'Phase 1' trial. This means it's the first time the medicine will be given to humans. Researchers will start with a small amount of BDT272 and gradually increase it, always watching very closely to see how people react.

The main aim is to find out two key things: first, is BDT272 safe for people to take? And second, how does the body handle the medicine? This includes understanding how it's absorbed, distributed, broken down, and removed from the body. By learning these things, doctors can decide if BDT272 has the potential to become a useful treatment for pain in the future.

Key takeaways

This study is testing a new medicine for pain (BDT272) for the first time in people.
It's looking for healthy adults, aged 18 and over.
The main goals are to find out if the medicine is safe and how the body processes it.
Participation helps scientists learn crucial information for future pain treatments.
You'll receive careful medical monitoring throughout the study.

Who may be eligible?

To join this study, you must be a healthy adult, aged 18 or older. Both men and women are welcome to take part.

Because this is the first time the medicine is being given to people, it's really important that participants are generally in good health. This helps the researchers clearly see how the new medicine affects the body without other health conditions making it complicated.

There will be other specific health checks and questions to make sure the study is right and safe for you. For example, they will ask about any medicines you currently take and your general medical history.

Quick self-check

Are you 18 years old or older?
Are you generally in good health?
Do you currently have moderate to severe pain?
Are you able to commit to several clinic visits and potential overnight stays?
Do you understand that this is not a pain treatment study, but a safety study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be given the new medicine, BDT272, in a hospital or clinic setting. The study will involve giving you a single dose at first, and then different groups of volunteers will receive gradually increasing doses. You will have regular check-ups, which include blood tests, urine tests, and monitoring your heart rate and blood pressure, to see how your body reacts to the medicine.

You might need to stay overnight in the clinic for some parts of the study, or attend several appointments over a period of time. The doctors and nurses will carefully explain what to expect at each visit. The total length of your participation, including follow-up visits after you've taken the medicine, will be made clear to you before you agree to take part.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. The main benefit here is contributing important knowledge that could lead to new ways to treat pain for many people. You will also receive careful medical attention and health monitoring throughout the study. Potential risks include possible side effects from the new medicine, which could range from mild, like a headache, to more serious, although extensive safety testing is done before human trials. You will be fully informed of all known and potential risks before you decide to join, and you can withdraw from the study at any time without giving a reason.

Locations (1)

—
France

Common questions

What is a 'Phase 1' study?

A Phase 1 study is the first time a new medicine is tested in humans. Its main purpose is to check for safety and how the body handles the medicine, not to treat a condition yet.

Will I receive treatment for my pain in this study?

No, this study is for healthy volunteers and is designed to test the medicine's safety and effects on the body, not to treat existing pain, as it's a very early stage of research.

How long will I need to be involved?

The exact duration can vary, but it will involve several visits to the clinic, possibly including overnight stays, and follow-up checks. The study team will tell you the precise timeline.

Will I get paid for taking part?

Many early-stage studies offer payment to recognise your time and commitment. This will be explained to you by the study team.

Can I leave the study once I've started?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.